Dioctyltin dilaurate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 October 2012 to 08 October 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dioctyltin dilaurate

EC Number:

222-883-3

EC Name:

Dioctyltin dilaurate

Cas Number:

3648-18-8

Molecular formula:

C40-H80-O4-Sn

IUPAC Name:

dioctyltin dilaurate

Test material form:

other: liquid (undefined)

Details on test material:

Storage: Room temperature in the dark.
State: Yellow liquid.

Test system

Amount / concentration applied:

10 µL of test material was applied topically.

Duration of treatment / exposure:

15 minutes.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: Relative viability (%)

Value:

101.8

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 15 minutes. Max. score: 100.0. (migrated information)

Any other information on results incl. tables

Direct MTT Reduction

The MTT solution containing the test material did not turn blue which indicated that the test material did not directly reduce MTT.

Main Test - Results

The relative mean viability of the test material treated tissues was 101.8 % after a 15 minute exposure period.

Table 1: Results

Item	OD540 of tissues	Mean OD540 of triplicate tissues	± SD of OD540 (%)	Relative individual tissue viability (%)	Relative mean viability (%)	± SD of Relaive mean viability (%)
Negative control item	0.727	0.725	0.044	100.3	100*	6.1
	0.680			93.8
	0.768			105.9
Positive control item	0.070	0.053	0.015	9.7	7.3	2.1
	0.046			6.3
	0.043			5.9
Test material	0.785	0.738	0.110	108.3	101.8	15.2
	0.612			84.4
	0.816			112.6

SD = standard deviation

* = the mean viability of the negative control tissues is set at 100 %

Quality Criteria

The relative mean tissue viability for the positive control treated tissues was 7.3 % relative to the negative control treated tissues and the standard deviation value of the percentage viability was 2.1 %. The positive control criterion was therefore satisfied.

The mean OD540 for the negative control treated tissues was 0.725 and the standard deviation value of the percentage viability was 6.1 %. The negative control acceptance criterion was therefore satisfied.

The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 15.2 %. The test material acceptance criterion was therefore satisfied.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test material was considered to be a non-irritant.

Executive summary:

The skin irritation potential of the test material was determined in vitro, in accordance with standardised guidelines OECD 439 and EU Method B.46 using the EPISKIN™ Reconstructed Human Epidermis (RHE) Model.

During the study triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.

At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre labelled 96 well plate. The optical density (OD) was measured at 540 nm (OD540).

Under the conditions of the study, the relative mean viability of the test material treated tissues was 101.8 % after the 15 minute exposure period. The quality control criteria required for acceptance of results were satisfied and the test material was concluded to be a non-irritant to the skin.